MENB1150_CB_Cert_3rd Ed

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Test Report issued under the responsibility of:
12
IEC 60601-1
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance
Report Reference No......................:
Date of issue ...................................:
Total number of pages...................:
CB Testing Laboratory...................:
Address ...........................................:
Applicant’s name ............................:
Address ...........................................:
Test specification:
Standard ..........................................:
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
Test procedure................................:
CB Scheme
Non-standard test method………..:
Test Report Form No......................:
IEC60601_1G
Test Report Form Originator .........:
Underwriters Laboratories Inc.
Master TRF ......................................:
Dated 2010-11
Test item description .................... :
Trade Mark ..................................... :
Manufacturer.................................. :
Model/Type reference.................... :
Page 2 of 309
Ratings............................................ :
Report No. E302267-12CA23553
Page 3 of 309
Testing procedure and testing location:
CB Testing Laboratory:
Testing location/ address................... :
Associated CB Test Laboratory:
Testing location/ address................... :
Tested by (name + signature) .. :
DongGug Cho
Approved by (+ signature) ....... :
DongYoul Kim
Testing procedure: TMP
Tested by (name + signature) .. :
Approved by (+ signature) ........ :
Testing location/ address................... :
Testing procedure: WMT
Tested by (name + signature) .. :
Witnessed by (+ signature) ....... :
Approved by (+ signature) ....... :
Testing location/ address................... :
Testing procedure: SMT
Tested by (name + signature) .. :
Approved by (+ signature) ....... :
Supervised by (+ signature)..... :
Testing location/ address................... :
Testing procedure: RMT
Tested by (name + signature) .. :
Approved by (+ signature) ....... :
Supervised by (+ signature)..... :
Testing location/ address................... :
Report No. E302267-12CA23553
Page 4 of 309
Report No. E302267-12CA23553
List of Attachments (including a total number of pages in each attachment):
Summary of testing
Tests performed (name of test and test clause):
Summary of compliance with National Differences
Copy of marking plate -
Testing location:
Page 5 of 309
Report No. E302267-12CA23553
GENERAL INFORMATION
Test item particulars (see also Clause 6):
Classification of installation and use ................................. :
Device type (component/sub-assembly/ equipment/
system) ................................................................................... :
Intended use (Including type of patient, application
location).................................................................................. :
Mode of operation ................................................................ :
Supply connection ............................................................... :
Accessories and detachable parts included ...................... :
Other options include ........................................................... :
Testing
Date of receipt of test item(s)................................................ :
Dates tests performed ........................................................... :
Possible test case verdicts:
- test case does not apply to the test object ...................:
- test object does meet the requirement ...........................:
- test object was not evaluated for the requirement.......... :
- test object does not meet the requirement ....................:
Abbreviations used in the report:
- normal condition ...................................................: N.C.
- means of Operator protection .............................: MOOP
General remarks:
Throughout this report a
comma /
point is used as the decimal separator.
Page 6 of 309
Report No. E302267-12CA23553
Manufacturer’s Declaration per sub-clause 6.2.5 of IECEE 02:
The application for obtaining a CB Test Certificate
includes more than one factory location and a
declaration from the Manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory
has been provided...................................................... :
Yes
Not applicable
When differences exist; they shall be identified in the General product information section.
Name and address of factory (ies)......................... :
Page 7 of 309
General product information:
Model Differences
Technical Considerations
Report No. E302267-12CA23553